Study on Blinatumomab, Methotrexate, Cytarabine, and Ponatinib for Treating Philadelphia Chromosome-Positive or Relapsed/Refractory Acute Lymphoblastic Leukemia

Sponsor: M.D. Anderson Cancer Center

Sponsor score: 0
Inactive

ClinicalTrials ID:NCT03263572

Provider View

This clinical trial is testing a combination of drugs, including blinatumomab, methotrexate, cytarabine, and ponatinib, to see how well they work in treating patients with a specific type of leukemia that is either Philadelphia chromosome-positive or has returned after treatment.

Patient Parameters

Program Overview

This study is exploring how well a combination of drugs—blinatumomab, methotrexate, cytarabine, and ponatinib—works in treating patients with acute lymphoblastic leukemia (ALL) that is either Philadelphia chromosome-positive or has come back after treatment. Blinatumomab is an immunotherapy that may help the immune system attack cancer cells. Methotrexate and cytarabine are chemotherapy drugs that stop cancer cells from growing. Ponatinib may block enzymes that cancer cells need to grow. The study aims to find out if this combination is more effective in treating this type of leukemia.

Description

The main goal of this study is to see how well the drug combination works in patients with newly diagnosed Philadelphia chromosome-positive acute lymphoblastic leukemia (ALL) and those whose disease has returned or not responded to treatment. Researchers will also look at other outcomes like survival rates and safety of the treatment.

Patients will receive blinatumomab through an IV continuously for 28 days in each cycle, along with methotrexate and cytarabine given by spinal tap on specific days. Ponatinib will be taken orally every day. Treatment cycles repeat every 6 weeks unless the disease progresses or side effects become too severe.

After finishing the treatment, patients will have follow-up visits 30 days later and then every 6 months.

Eligibility Criteria

Inclusion Criteria

  • Adults aged 18 or older with a specific type of leukemia that is Philadelphia chromosome-positive or has returned after treatment.
  • Must have a performance status score of 2 or less, indicating they are able to carry out daily activities with some limitations.
  • Must have adequate liver and pancreatic function based on specific blood tests.
  • Women of childbearing potential must have a negative pregnancy test and agree to use effective birth control during the study and for 4 months after.
  • Men must agree to use effective birth control during the study and for 4 months after.
  • Must have adequate heart function as determined by a doctor.
  • Must provide signed informed consent to participate in the study.

Exclusion Criteria

  • Have an active serious infection not controlled by antibiotics.
  • Have a history of pancreatitis or alcohol abuse.
  • Have uncontrolled high triglycerides in the blood.
  • Have another active cancer that could shorten life expectancy to less than a year.
  • Have severe heart problems or uncontrolled high blood pressure.
  • Have a history of significant brain or nervous system disorders.
  • Have an autoimmune disease that could affect the brain.
  • Have received other investigational cancer treatments within 2 weeks before the study.
  • Are pregnant or breastfeeding.
  • Have a history of significant bleeding disorders.
  • Have significant fluid buildup around the lungs or heart unless related to leukemia.
  • Have active infections like HIV, hepatitis B, or hepatitis C.

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